Regulatory approval
Published by the Health Canada.
Health Canada approved osimertinib as adjuvant therapy after tumour resection in patients with stage IB-IIIA1 non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations.
This is written in the approval document as:
TAGRISSO (osimertinib) is indicated as adjuvant therapy after tumour resection in patients with stage IB-IIIA1 non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations.
Citation
Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.
| Organization(s) | Biomarker(s) | Cancer type | Therapy(ies) | |
|---|---|---|---|---|
| HC (1) | EGFR Exon 19 (Deletion) | Non-Small Cell Lung Cancer | Osimertinib | |
| HC (1) | EGFR p.L858R | Non-Small Cell Lung Cancer | Osimertinib |